Safety of Anticoagulant Therapy After Endoscopic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-06-28

Brief Summary

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The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.

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Detailed Description

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Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.

Conditions

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Cirrhosis Portal Vein Thrombosis Esophageal and Gastric Varices Anticoagulant-induced Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NWS group

nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months

Group Type EXPERIMENTAL

nadroparin calcium-warfarin sequential anticoagulation

Intervention Type DRUG

The NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.

control group

no anticoagulation therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nadroparin calcium-warfarin sequential anticoagulation

The NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.

Intervention Type DRUG

Other Intervention Names

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anticoagulation

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of cirrhosis
* Portal hypertension with esophageal and gastric varices
* diagnosis of PVT by imaging examination
* undergo endoscopic therapy

Exclusion Criteria

* older than 75 years
* uncontrolled active bleeding
* hepatocellular carcinoma or other extrahepatic malignancy
* on-going or received antithrombotic/thrombolytic treatment
* previous treatment with TIPSS
* cavernous transformation of the portal vein
* platelet count lower than 10\*10 \^ 9/L, creatinine more than 170 μmol/L
* Budd-Chiari syndrome
* pregnancy or breast-feeding period
* severe cardiopulmonary diseases, severe systemic infection or sepsis
* inability to sign informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No